(35 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between paties: and examiner (21CFR 880.6250)
Patient Vinyl Examination Gloves, Powdered
The provided document is a 510(k) premarket notification letter from the FDA for a device described as "Patient Vinyl Examination Gloves, Powdered." This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/ML device testing. It is a regulatory clearance document for a traditional medical device (gloves), indicating that it has been found substantially equivalent to a predicate device.
Therefore, I cannot provide the requested information from this document. The questions about acceptance criteria, sample size, ground truth, expert qualifications, and AI study details are not applicable to the content of this regulatory letter.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.